The FDA has linked the deaths of 561 people in the US to the use of apnea machines from one brand of home appliances.

United States Food and Drug Administration ,fda) links the deaths of 561 people to the use of the brand’s sleep apnea machines PHILIPSparticular device model cpap And BiPAP Which were withdrawn from the market in 2021.

Such machines are commonly used to treat people sleep apneaa disorder defined by cleveland clinic A disorder that causes a person to stop breathing while sleeping, causing the brain to partially wake them up to breathe, but thus preventing restful sleep. It is estimated that sleep apnea affects approximately billion people around the world According to a study by National Institute of Health,

As published CBS NewsFrom April 2021, fda More than 116,000 reports of medical incidents related to foam erosion in machines cpap and sleep therapy devices BiPAP Of PHILIPSWhich also includes death report.

In fact, only in the middle july And September 2023More than 7,000 medical device reports were received There were reports of 111 related deaths As per the data collected by the agency, the use of the said machines reuters,

the problem lies in polyurethane foam Polyester-based is used in appliances Reduce sound and vibration, which can cause breakageOngoing “small pieces of foam or invisible chemicalsWhich users can inhale or swallow. fda These events are classified as potentially serious, which “may require medical intervention to prevent permanent injuries.”

In June 2021The company almost announced its decision to withdraw from the market 5.5 million devices Globally, there is a subsequent recall, even of already repaired fans, for repair or replacement.

Philips RespironicsThe company behind these teams has been at the center of controversy. The company claimed that “Related complaints have been received and will continue to be received For devices that are subsequently filed with a health regulator as a medical device report usa, However, PHILIPS It says it has “not found conclusive data linking these devices and the reported deaths.”

According to reutersThe company faces court cases brought by patients who claim to have suffered decline in your health Due to the use of these devices. Added to this, PHILIPS is under the magnifying glass United States Department of Justicewhich launched an investigation into the handling of the recall of the products involved.

This situation has caused PHILIPS To take Strict measures regarding its operations in the United States, The company announced early last week that it would not sell new devices to treat sleep apnea. usa In the following years.

He The financial and legal implications for Philips are substantial.Since in 2023, they agreed to compensate at least 479 million dollars For users of 20 different breathing devices and ventilators were sold in the United States Between 2008 and 2021 People, The proposed settlement, which arose from a class-action lawsuit, provided for reimbursement of financial losses related to the purchase, rental or lease of the recalled equipment.

Affected users have the right to claim compensationWhich includes “Device Payment”, “Device Return Rebate” for each device purchased, rented or leased 100 dollars “Device Replacement Award” for each device returned before August 9, 2024, and/or money spent on the purchase of a comparable machine to replace the recalled device between June 14, 2021, and June 7, 2021 “.